MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SIMON NITINOL FILTER SYSTEM; VENA CAVA FILTER

Model Number 2120F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Pulmonary Embolism (1498)

Event Date 06/02/2014

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2016).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis, pelvic hematoma while on systemic anticoagulation and renal failure.At some time post filter deployment, a computed tomography (ct) abdomen without intravenous and with oral contrast and multiphase axial images using computed tomography (ct) abdomen and pelvis with intravenous contrast revealed that the filter tilted anteroposteriorly and filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with acute pulmonary embolism; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately two weeks later, the patient¿s admitting diagnosed showed acute pulmonary embolism and deep vein thrombosis.After one month, a computed tomography angiography (cta) chest with contrast showed that there was no pulmonary embolus or new right dissection.There was a metallic density that projected just posterior to the pancreas and might be a migrated clip.After nine months, axial images using computed tomography (ct) abdomen without intravenous and with oral contrast and multiphase axial images using computed tomography (ct) abdomen and pelvis with intravenous contrast showed that there was a simon nitinol vena cava filter in place.The superior tip of the filter was positioned 1.5 cm inferior to the right renal vein.There was no significant mediolateral tilting of the inferior vena cava filter.There was 21-degree anteroposterior tilting of the inferior vena cava filter.The tip of the filter was apposed to the anterior wall of the inferior vena cava.This was consistent with an embedded filter.There was no evidence of filter fracture and inferior vena cava thrombosis.There were 6 filter struts present.All 6 of these struts appear positioned outside the inferior vena cava.The struts located in the 11:00 and 1:00 position abutted loops of small bowel; this represented grade 3 perforation.The strut located in the 9:00 position abutted the right ureter and right gonadal vein; this represented grade 3 perforation.There was a fat plane seen between the 7:00 position strut and the inferior vena cava wall; this represented grade 2 perforation.The struts located in the 3:00 and 5:00 position appeared outside the wall, but without an intervening fat plane between the struts and the inferior vena cava wall; this represented grade 1 perforation.After seven months, a computed tomography (ct) abdomen and pelvis without oral or intravenous contrast showed that there was a simon nitinol inferior vena cava filter in place.The superior tip of the filter was positioned 1.5 cm inferior to the right renal vein, unchanged.There was no significant mediolateral tilting of the inferior vena cava filter.There was 19-degrees anteroposterior tilting of the inferior vena cava filter, not significantly changed.The tip of the filter was apposed to the anterior wall of the inferior vena cava.This was consistent with an embedded filter.There was no evidence of filter fracture.Definitive evaluation for inferior vena cava thrombosis was limited by the lack of intravenous contrast.However, there was no abnormal enlargement or diminution in size of the inferior vena cava to suspect thrombus formation.There were 6 filter struts present.All 6 of these struts appear positioned outside the inferior vena cava.The strut located in the 11:00 position abutted a loop of small bowel; this represented grade 3 perforation.The loop of bowel that abutted the 1:00 position strut on the previous exam had moved to a slightly different location than the previous exam, due to peristalsis; it therefore no longer abutted the 1:00 position strut.There was a distinct fat plane seen between this strut and the inferior vena cava wall.This represented grade 2 perforation.The strut located in the 9:00 position abutted the right ureter and right gonadal vein; this represented grade 3 perforation.There was a fat plane seen between the 7:00 position strut and the inferior vena cava wall; this represented grade 2 perforation.The strut located in the 5:00 position appeared outside the wall, but without an intervening fat plane between the strut and the inferior vena cava wall; this represented grade 1 perforation.The strut located in the 3:00 position abutted the right aspect of the abdominal aorta; this represented grade 3 perforation.After one month, axial images using computed tomography (ct) abdomen without intravenous and with oral contrast and multiphase axial images using computed tomography (ct) abdomen and pelvis with intravenous contrast showed that there was a simon nitinol inferior vena cava filter in place.The superior tip of the filter was positioned 1.5 cm inferior to the right renal vein, unchanged.There was no significant mediolateral tilting of the inferior vena cava filter.There was 19-degree anteroposterior tilting of the inferior vena cava filter, not significantly changed.The tip of the filter was apposed to the anterior wall of the inferior vena cava.This was consistent with an embedded filter.There was no evidence of filter fracture.There was no evidence of inferior vena cava thrombosis.There were 6 filter struts present.All 6 of these struts appear positioned outside the inferior vena cava.The strut located in the 11:00 position abutted a loop of small bowel; this represented grade 3 perforation.The strut located in the 1:00 position abutted a loop of small bowel; this represented grade 3 perforation.The strut located in the 9:00 position abutted the right ureter and right gonadal vein; this represented grade 3 perforation.There was a fat plane seen between the 7:00 position strut and the inferior vena cava wall; this represented grade 2 perforation.The strut located in the 5:00 position was now in contact with the pre-vertebral soft tissues.Additionally, there was a defect in the anterior-inferior aspect of the l3 vertebral body consistent with bone re-modeling, due to contact with this strut; this represented grade 3 perforation.The strut located in the 3:00 position abutted the right aspect of the abdominal aorta; this represented grade 3 perforation.After one year and three months, axial images using computed tomography (ct) abdomen and pelvis without oral or intravenous contrast showed that there was a simon nitinol inferior vena cava filter in place.The superior tip of the filter was positioned 1.5 cm inferior to the right renal vein, unchanged.There was no significant mediolateral tilting of the inferior vena cava filter.There was 19-degree anteroposterior tilting of the inferior vena cava filter, not significantly changed.The tip of the filter was apposed to the anterior wall of the inferior vena cava.This was consistent with an embedded filter.There was no evidence of filter fracture.Definitive evaluation for inferior vena cava thrombosis was limited by the lack of intravenous contrast.However, there was no abnormal enlargement or diminution in size of the inferior vena cava to suspect thrombus formation.There were 6 filter struts present.All 6 of these struts appear positioned outside the inferior vena cava.The struts located in the 11:00 and 1:00 positions appeared outside the inferior vena cava.The adjacent small bowel had changed in position and the struts were no longer in contact with bowel; therefore, this represented grade 1 perforation.The strut located in the 9:00 position abutted the right ureter and gonadal vein; this represented grade 3 perforation.There was a fat plane seen between the 7:00 position strut and the inferior vena cava wall; this represented grade 2 perforation.The strut located in the 5:00 position remained in contact with the pre-vertebral soft tissues.Additionally, there was a defect in the anterior-inferior aspect of the l3 vertebral body again seen consistent with bone remodeling, due to contact with this strut; this represented grade 3 perforation.The strut located in the 3:00 position abutted the right aspect of the abdominal aorta; this represented grade 3 perforation.Therefore, the investigation is confirmed for alleged filter tilt, perforation of the inferior vena cava.Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment.However, the relationship to the filter is unknown.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: d4 (expiry date: 10/2016), g4.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis, pelvic hematoma while on systemic anticoagulation and renal failure.At some time post filter deployment, a computed tomography (ct) abdomen without intravenous and with oral contrast and multiphase axial images using computed tomography (ct) abdomen and pelvis with intravenous contrast revealed that the filter tilted anteroposteriorly and filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with acute pulmonary embolism; however, the current status of the patient is unknown.

• Brand Name: SIMON NITINOL FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11291336
• MDR Text Key: 230675377
• Report Number: 2020394-2021-80153
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (y/n): N
• PMA/PMN Number: K970099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: GFXI2498
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOVENOX; LOVENOX; LOVENOX
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR